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A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype

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ClinicalTrials.gov Identifier: NCT04981275
Recruitment Status : Recruiting
First Posted : July 28, 2021
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
University of Maryland, Baltimore
Information provided by (Responsible Party):
Onegevity Health

Brief Summary:

The purpose of this research study is to explore the relationship between the gut microbiome and hormone levels in women diagnosed with PCOS and determine whether there are differences in the gut microbiome between women with PCOS and women without PCOS.

Consented, enrolled participants will complete a health questionnaire, complete a fasted blood draw at a local laboratory, and provide a stool, saliva, and vaginal swab sample for comprehensive biomarkers, hormones, metagenomics, and metabolomics analysis.


Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Other: No intervention study

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Study Type : Observational
Estimated Enrollment : 175 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype
Actual Study Start Date : June 19, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Women with PCOS
Women previously diagnosed with PCOS not using hormonal therapy and without other significant health or endocrine issues
Other: No intervention study
This observational study will only collect data, not provide any intervention to participants.

Healthy controls
Women self-identifying as generally healthy, not using hormonal therapy, and without any significant health or endocrine issues
Other: No intervention study
This observational study will only collect data, not provide any intervention to participants.




Primary Outcome Measures :
  1. Phenotype differences in vaginal microbiome [ Time Frame: Samples to be collected on any day once per participant within 30 days of enrollment ]
    Understand phenotypical differences from biological samples comparing women with and without PCOS. Vaginal swabs are to be collected by women and analyzed with metagenomics and metabolomics sequencing.

  2. Phenotype differences in gut microbiome [ Time Frame: Samples to be collected once on any day per participant within 30 days of enrollment ]
    Understand phenotypical differences from biological samples comparing women with and without PCOS. Stool samples are to be collected by women and analyzed with metagenomics sequencing.

  3. Phenotype differences in blood biomarkers [ Time Frame: Samples to be collected once within a 5-day window to control for menstrual cycle, within 30 days of enrollment ]
    Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory, for a comprehensive analysis of targeted hormones and untargeted metabolic systems.

  4. Phenotype differences in DNA [ Time Frame: Samples to be collected once per participant within 30 days of enrollment ]
    Understand phenotypical differences from biological samples comparing women with and without PCOS. Saliva samples are to be collected and analyzed by a commercial laboratory for DNA and metabolomics.


Biospecimen Retention:   Samples With DNA
Whole blood, saliva, vaginal microbiome, stool microbiome


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women, ages 18-40, living in the USA (except for NY, NJ, RI, MD, SD, ND, or HI), who have not been using hormonal therapy for at least 3 months and without other significant health issues or medications affecting hormones. Women must be previously diagnosed with PCOS or considered Healthy and not currently pregnant or nursing. Women will be referred to the study by their Physician or word of mouth.
Criteria

Inclusion Criteria:

  • Women diagnosed with PCOS or Women who are considered Healthy
  • 18-40 years old
  • Residing in the USA, except for exclusion states
  • Have not been using hormonal therapy for at least 3 months

Exclusion Criteria:

  • Women using hormonal therapy within the last 3 months
  • Diagnosed with other significant health conditions or using medications that will affect hormone levels
  • Residing in NY, NJ, MD, RI, ND, SD, or HI
  • Pregnant or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981275


Contacts
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Contact: Laura J Kunces, PhD 12034157925 studycoordinator@onegevity.com

Locations
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United States, Maryland
University of Maryland Recruiting
College Park, Maryland, United States, 20742
Contact: Laura J Kunces, PhD    203-415-7925    studycoordinator@onegevity.com   
Sponsors and Collaborators
Onegevity Health
University of Maryland, Baltimore
Investigators
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Principal Investigator: Chris D'Adamo, PhD University of Maryland, College Park
Principal Investigator: Chris Mason, PhD Weill Medical College of Cornell University
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Responsible Party: Onegevity Health
ClinicalTrials.gov Identifier: NCT04981275    
Other Study ID Numbers: HP-00089723
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases